Clearance Summary
IMMUNODIFFUSION BAND INTENSIFYING FLUID received FDA 510(k) clearance under submission number K812194, sponsored by American Scientific Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-08-31.
- Submission: K812194
- Applicant / Sponsor: American Scientific Products
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4500
- Decision date: 1981-08-31
Classification & Regulation
This clearance is catalogued under FDA product code JZS and 21 CFR 866.4500, within the Immunology review panel as a Class I device.